The present disclosure relates to medical devices used in implant surgery. More specifically, the present disclosure relates to a Furlow insertion tool and Keith needle.
The study of impotence has recently become center stage in the field of medicine. In the early 1970's, the conventional view was that ninety percent of impotence cases were psychologically based, whereas only ten percent of the cases were caused by a physical condition. Today, doctors and scientists understand that the overwhelming majority of cases are caused by a physical condition. Accordingly, more and more resources are poured into the study of and treatment for impotence. In a recent study, fifty-two percent of men between the ages of forty and seventy self-reported that they suffer from some type of erectile dysfunction. Another study estimated that over thirty million American men and their partners suffer from erectile dysfunction.
Advertisements for pharmaceutical treatments for impotence have become ubiquitous, and include endorsements from celebrities that suffer from erectile dysfunction. More and more men and their partners now are seeking treatment for impotence. In the recent past, it was estimated that only one in twenty suffers of erectile dysfunction sought treatment from their doctors. Pharmaceutical treatments are successful for only a subset of impotence sufferers. More invasive treatments are necessary for many men. These treatments include injection therapy, vacuum devices and penile prosthesis.
For many impotence sufferers, the penile prosthesis, or penile implant, is the only solution to restore a happy and healthy sex life. The penile implant has been used for decades and provides a selected and reliable erection. The penile implant often includes a pair of cylinders. In some instances, these cylinders are inflatable, which are connected to a fluid-filled reservoir with a pump and valve assembly. The two cylinders are normally implanted into the corpus cavernosae of the patient's penis and the reservoir is typically implanted into the patient's abdomen. The pump assembly is implanted in the scrotum. During use, the patient actuates the pump and fluid is transferred from the reservoir through the pump and into the cylinders. This results in the inflation of the cylinders and produces rigidity for a normal erection. Then, when the patient desires to deflate the cylinders, a valve assembly within the pump is actuated in a manner such that the fluid in the cylinders is released back into the reservoir. This deflation returns the penis to a flaccid state.
The penile implant is an invasive treatment and requires a delicate and painful implant surgery to install. To reach the corpus cavernosum and implant the cylinders, the surgeon will first make an incision at the base of the penis, such as where it meets the scrotum. The patient is prepared for the cylinder after the surgeon has dilated each corpus cavernosum to create space for the cylinders.
Once the patient has been prepared, the surgeon will insert a medical device known as a Furlow insertion tool with a Keith needle into the dilated corpus cavernosum. The Furlow tool is a well known and often used device in the art and is described in U.S. Pat. No. 4,244,370, which was filed in 1978. The Furlow tool is a long slender device having a hollow barrel with a plunger device known as an obturator at the rearward end. The Keith needle is also a well-known article used in many areas of medicine that looks much like a heavy straight sewing needle, but is used instead to pierce tissue. The Keith needle fits within the barrel and is ejected from the forward end with the obturator.
In order to install the implant, the Keith needle is attached to a suture that is also attached to the cylinder. The Furlow tool is advanced into the corpus cavernosum until the forward end is inside of the crown of the penis, or glans. At this point, the cylinder and part of the suture attached to the cylinder remain outside of the patient's body. The Furlow tool is used to force the Keith needle out of the barrel and through the glans. The surgeon grasps the Keith needle from outside of the body and pulls it from the penis leaving the suture threaded through the corpus cavernosum. The Furlow tool is withdrawn from the penis. The suture is then pulled to draw the cylinder into the incision and the corpus cavernosum. Once the implant is in place, the suture is removed. This procedure is performed for each corpus cavernosum. The incision at the base of the penis is closed and the hole in the glans from the Keith needle is permitted to heal closed. The recovery process can be several weeks to a few months.
As mentioned, Keith needles are used in many areas of medicine. One such use has been to puncture a patient's chest to adjust pacemaker settings. The Keith needle often used in penile implant surgery is often an abdominal Keith needle and includes a triangular cross section and an eye. The cross sectional width of the Keith needle is less than the diameter of the bore in the hollow barrel of the Furlow tool. One reason is that the bore must also accommodate the suture extending through the eye of the needle. A narrow Keith needle is preferred to reduce trauma as it pierces the penis.
A surgeon typically encounters several issues when inserting the Furlow tool and ejecting the Keith needle. One issue with this configuration is that the Keith needle could fall out of the barrel under the force of gravity. If the medical personnel are not careful, the Keith needle could fall out and they could pierce themselves, the patient, or the inflatable cylinder, which could damage or ruin the cylinder. This problem is prevalent and many medical professionals have now adopted a specialized grip on the suture and the barrel when handling the Furlow tool. This grip, in addition to being uncomfortable, often leads to the medical professional's surgical gloves being pinched or caught in the Furlow tool.
Another issue often encountered by the surgeon relates to the fact that the Keith needle can rest “off-axis” inside the wider barrel of the Furlow tool. If the needle exits the Furlow tool at an angle, it can track incorrectly through the penis and exit the glans at an unintended or undesired location. This may require the surgeon to re-pierce the penis, causing further trauma.